00:34 , Dec 31, 2016 |  BioCentury  |  Finance

SMA(ll) wonder

It’s a mystery why investors shaved 10% off gene therapy company AveXis Inc. (NASDAQ:AVXS) following FDA’s approval of Spinraza nusinersen for spinal muscular atrophy from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS). Spinraza has...
08:00 , Feb 1, 2016 |  BC Week In Review  |  Clinical News

Pyridoxamine: Phase III ongoing

NephroGenex said an independent DSMB recommended continuation of the double-blind, placebo-controlled, international Phase III PYR-311 trial evaluating 300 mg oral Pyridorin twice daily until ESRD or death occurs. The trial, which has an SPA from...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

Masitinib: Completed Phase III enrollment

AB Science completed enrollment of 381 patients in a double-blind, placebo-controlled, European Phase III trial of oral masitinib plus riluzole. AB Science S.A. (Euronext:AB), Paris, France   Product: Masitinib ( Masican) ( AB1010)   Business: Neurology   Molecular...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Clinical News

Astragraf XL tacrolimus: Phase IIIb data

The open-label, international Phase IIIb DIAMOND trial in 893 patients showed that once-daily low-dose (0.15-0.175 mg/kg) Advagraf in combination with Simulect basiliximab and mycophenolate mofetil (MMF) met the primary endpoint of increasing GFR as...
08:00 , Jan 19, 2015 |  BC Week In Review  |  Clinical News

Masitinib: Phase III ongoing

AB Science said an independent DSMB recommended continuation of a double-blind, placebo-controlled, European Phase III trial of oral masitinib plus riluzole based on a review of safety data. The company said there are no safety...
03:53 , Oct 22, 2014 |  BC Extra  |  Politics & Policy

FDA backs further study of kidney biomarkers

FDA issued its first Letter of Support for two kidney biomarkers identified by the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute (C-Path). Elevated levels of the two biomarkers, osteopontin (OPN) and neutrophil...
07:00 , Jul 14, 2014 |  BC Week In Review  |  Clinical News

Pyridorin pyridoxamine: Phase III started

NephroGenex began the double-blind, placebo-controlled, international Phase III PYR-311 trial to evaluate 300 mg oral Pyridorin twice daily until ESRD or death occurs in about 600 patients with nephropathy due to Type II diabetes. PYR-311...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Clinical News

Kiacta eprodisate: Completed Phase III enrollment

Auven completed enrollment of 230 patients in a double-blind, placebo-controlled, international Phase III trial of oral 400 mg Kiacta. Patients will receive 1-3 capsules of Kiacta twice daily and the dosing will be adjusted in...
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

Kiacta eprodisate: Phase III ongoing

Bellus disclosed in its 3Q13 earnings that in October a DSMB recommended continuation of a double-blind, placebo-controlled, international Phase III trial of oral Kiacta in about 230 patients based on safety data. The product has...
08:00 , Nov 11, 2013 |  BC Week In Review  |  Clinical News

Masitinib: Phase II amended

AB Science amended an ongoing, double-blind, placebo-controlled, European Phase II trial of oral masitinib plus riluzole to designate it as a Phase III trial and increase enrollment to 210 patients from 45. Masitinib is in...